Effectiveness of Chitosan Covered Gauze to Stop Bleeding in Post-partum TearsNCT06998641
EFFECTIVITY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS
A study testing Chitosan-covered-gauze application and Suturation in people with Effectiveness of Chitosan Covered Gauze to Stop Bleeding in Post-partum Tears and Comparison of the Effect of Chitosan Covered Gauze With Suturing in Terms of Hemostasis in Post-partum Haemorrhagic Tears, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the efficacy of different treatment methods that can be used in the treatment of hemorrhagic tears that may occur in the postpartum period. The volunteers who will participate in the study will be evaluated during the hospitalization period after delivery and at the end of the… Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Effectiveness of Chitosan Covered Gauze to Stop Bleeding in Post-partum Tears, Comparison of the Effect of Chitosan Covered Gauze With Suturing in Terms of Hemostasis in Post-partum Haemorrhagic Tears
- What is being tested?
- Chitosan-covered-gauze application and Suturation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who delivered at the Department of Obstetrics and Gynecology of Istanbul Training and Research Hospital between March 2025 and March 2027.
- Age between 18 and 48 years.
- Presence of a bleeding postpartum obstetric laceration (first- or second-degree) without an anatomical defect requiring surgical repair.
- Absence of additional conditions that may affect the amount of postpartum bleeding, such as uterine atony or retained placental tissue.
- Provision of written informed consent for participation in the study.
Who cannot join
- Age younger than 18 years or older than 48 years.
- Absence of a bleeding postpartum first- or second-degree obstetric laceration meeting the study criteria.
- Presence of an obstetric laceration with an anatomical defect requiring surgical repair.
- Presence of additional causes or conditions that may affect postpartum blood loss, such as uterine atony or retained placental tissue.
- Failure to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Training and Research Hospital Department of Obstetrics and Gynecology
Istanbul
Doruk C Katlan, +90 535 347 54 11, dcek2000@yahoo.com
Nebahat Uzunay, + 90 505 260 94 36, nebahatuzunay@gmail.com
About this study
This study was planned to investigate the efficacy of different treatment methods that can be used in the treatment of hemorrhagic tears that may occur in the postpartum period. The volunteers who will participate in the study will be evaluated during the hospitalization period after delivery and at the end of the puerperium 6 weeks after delivery, in accordance with routine postpartum control examinations. In the treatment of postpartum hemorrhagic tears, the treatment options such as suturing the tears to stop bleeding or applying tampons with bleeding stopping agent (chitosan) and compression effect to the torn area will be determined completely randomly.
- Conditions
- Effectiveness of Chitosan Covered Gauze to Stop Bleeding in Post-partum Tears, Comparison of the Effect of Chitosan Covered Gauze With Suturing in Terms of Hemostasis in Post-partum Haemorrhagic Tears
- Being tested
- Chitosan-covered-gauze application, Suturation
- Keywords
- chitosan-covered-gauze, post-partum lacerations, obstetrical tears
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitosan-covered-gauze applicationProcedure or surgery
Effectiveness of chitosan-covered-gauze in terms of patients' comfort and satisfaction, hospital stay, total amount of bleeding, hemoglobin decline and other complications (infections, need for transfusion etc.) for the treatment of hemorrhagic obstetrical tears
SuturationProcedure or surgery
Effectiveness of suturation in terms of patients' comfort and satisfaction, hospital stay, total amount of bleeding, hemoglobin decline and other complications (infections, need for transfusion etc.) for the treatment of hemorrhagic obstetrical tears
| Study group | Role | What they receive |
|---|---|---|
| chitosan-covered-gauze applied tears | Experimental | Hemostasis of the tears is obtained by the application of chitosan-covered-gauze Receives: Procedure: Chitosan-covered-gauze application |
| Suturation group | Active comparator | Hemostasis of the tears is obtained by suturing Receives: Procedure: Suturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of bleeding
Total amount of blood which is calculated by subtracting the dry weight of surgical absorbant gauze materials from their soaked weight
Measured: From time of birth to the cessation of bleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of Chitosan Covered Gauze to Stop Bleeding in Post-partum TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Doruk Cevdi Katlan, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998641
- Sponsor's protocol ID
- ISTANBUL TRH - 21.03.2025 - 65
- Status last verified
- Aug 2026
- First submitted
- 22 May 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVITY OF CHITOSAN COVERED GAUZE IN POSTPARTUM HEMORRHAGIC OBSTETRIC LACERATIONS
- ClinicalTrials.gov ID
- NCT06998641
- Acronym / sponsor ID
- ISTANBUL TRH - 21.03.2025 - 65
- Conditions
- Effectiveness of Chitosan Covered Gauze to Stop Bleeding in Post-partum Tears, Comparison of the Effect of Chitosan Covered Gauze With Suturing in Terms of Hemostasis in Post-partum Haemorrhagic Tears
- Keywords
- chitosan-covered-gauze, post-partum lacerations, obstetrical tears
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was planned to investigate the efficacy of different treatment methods that can be used in the treatment of hemorrhagic tears that may occur in the postpartum period. The volunteers who will participate in the study will be evaluated during the hospitalization period after delivery and at the end of the puerperium 6 weeks after delivery, in accordance with routine postpartum control examinations. In the treatment of postpartum hemorrhagic tears, the treatment options such as suturing the tears to stop bleeding or applying tampons with bleeding stopping agent (chitosan) and compression effect to the torn area will be determined completely randomly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chitosan-covered-gauze applied tears | Experimental | Procedure: Chitosan-covered-gauze applicationHemostasis of the tears is obtained by the application of chitosan-covered-gauze |
| Suturation group | Active comparator | Procedure: SuturationHemostasis of the tears is obtained by suturing |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women who delivered at the Department of Obstetrics and Gynecology of Istanbul Training and Research Hospital between March 2025 and March 2027.
- Age between 18 and 48 years.
- Presence of a bleeding postpartum obstetric laceration (first- or second-degree) without an anatomical defect requiring surgical repair.
- Absence of additional conditions that may affect the amount of postpartum bleeding, such as uterine atony or retained placental tissue.
- Provision of written informed consent for participation in the study.
Key exclusion criteria (5 listed)
- Age younger than 18 years or older than 48 years.
- Absence of a bleeding postpartum first- or second-degree obstetric laceration meeting the study criteria.
- Presence of an obstetric laceration with an anatomical defect requiring surgical repair.
- Presence of additional causes or conditions that may affect postpartum blood loss, such as uterine atony or retained placental tissue.
- Failure to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chitosan-covered-gauze applicationEffectiveness of chitosan-covered-gauze in terms of patients' comfort and satisfaction, hospital stay, total amount of bleeding, hemoglobin decline and other complications (infections, need for transfusion etc.) for the treatment of hemorrhagic obstetrical tears | Procedure or surgery | chitosan-covered-gauze applied tears |
| SuturationEffectiveness of suturation in terms of patients' comfort and satisfaction, hospital stay, total amount of bleeding, hemoglobin decline and other complications (infections, need for transfusion etc.) for the treatment of hemorrhagic obstetrical tears | Procedure or surgery | Suturation group |
Primary outcome
Amount of bleeding
Time frame: From time of birth to the cessation of bleeding
Total amount of blood which is calculated by subtracting the dry weight of surgical absorbant gauze materials from their soaked weight
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chitosan-covered-gauze application and Suturation in people with Effectiveness of Chitosan Covered Gauze to Stop Bleeding in Post-partum Tears and Comparison of the Effect of Chitosan Covered Gauze With Suturing in Terms of Hemostasis in Post-partum Haemorrhagic Tears, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doruk C Katlan (+90 535 347 54 11, dcek2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of bleeding (time frame: From time of birth to the cessation of bleeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.